You are on page 1of 26

Official reprint from UpToDate®

www.uptodate.com ©2020 UpToDate, Inc. and/or its affiliates. All Rights Reserved.

Permanent cardiac pacing: Overview of devices and


indications
Author: Mark S Link, MD
Section Editor: N A Mark Estes, III, MD
Deputy Editor: Susan B Yeon, MD, JD, FACC

All topics are updated as new evidence becomes available and our peer review process is complete.

Literature review current through: Oct 2020. | This topic last updated: Apr 23, 2020.

INTRODUCTION

Cardiac pacemakers are effective treatments for a variety of bradyarrhythmias. By


providing an appropriate heart rate and heart rate response, cardiac pacing can
reestablish effective circulation and more normal hemodynamics that are
compromised by a slow heart rate.

This topic will present a broad review of the role of cardiac pacing in a variety of
settings. The management of the specific disorders is discussed separately as is a
description of the different types of pacemakers and pacing modes. (See "Sinus node
dysfunction: Treatment" and "Third degree (complete) atrioventricular block" and
"Second degree atrioventricular block: Mobitz type II" and "Modes of cardiac pacing:
Nomenclature and selection".)

GENERAL CONSIDERATIONS

Despite the myriad of clinical situations in which permanent pacing is considered,


most management decisions regarding permanent pacemaker implantation are
driven by the following clinical factors:
● The association of symptoms with a bradyarrhythmia
● The location of the conduction abnormality
● The absence of a reversible cause

Symptoms — Patients are often evaluated for permanent cardiac pacemaker


placement because of symptoms that may be due to bradyarrhythmias (eg, dizziness,
lightheadedness, syncope, fatigue, and poor exercise tolerance). These patients will
often have evidence of persistent or intermittent sinus node dysfunction or
atrioventricular (AV) conduction abnormalities.

Establishing a direct correlation between symptoms and bradyarrhythmias, typically


by taking a careful history and documenting the cardiac rhythm with either an
electrocardiogram or ambulatory monitoring (external or insertable cardiac monitor
[also sometimes referred to as an implantable cardiac monitor or an implantable loop
recorder]), is essential for choosing the optimal candidates for pacemaker insertion
[1]. A direct correlation between symptoms and bradyarrhythmias will increase the
likelihood of pacemaker therapy resulting in clinical improvement. Conversely, failure
to document such a correlation, or the presence of an alternative explanation for
symptoms, decreases the likelihood of benefit from pacemaker insertion.

Location of conduction abnormality — The location of an AV conduction abnormality


(ie, within the AV node or below the AV node in the His-Purkinje system) is an
important determinant of both the probability and the likely pace of progression of
conduction system disease ( figure 1). (See "Second degree atrioventricular block:
Mobitz type I (Wenckebach block)" and "Second degree atrioventricular block: Mobitz
type II".)

Disease within the AV node is suggested by the following:

● First degree AV block with significant PR prolongation (see "First degree


atrioventricular block")
● Second degree AV block, Mobitz type I (Wenckebach) (see "Second degree
atrioventricular block: Mobitz type I (Wenckebach block)")
● Normal QRS complex

Disease below the AV node, in the His-Purkinje system, is suggested by:

● Normal or minimally prolonged PR interval


● Second degree AV block, Mobitz type II (see "Second degree atrioventricular block:
Mobitz type II")
● Third degree (complete) AV block (see "Third degree (complete) atrioventricular
block")
● Widening of the QRS complex (bundle branch block and/or fascicular block)

Disease in the His-Purkinje system is generally considered to be less stable and more
likely to progressively worsen. As a result, permanent pacemaker placement is more
likely to be recommended, as more likely to provide significant clinical benefit, in such
patients.

Reversible causes — In addition to intrinsic conduction system disease, there are a


number of extrinsic causes of bradyarrhythmias which are reversible. While patients
who have a reversible bradyarrhythmia may require temporary pacemaker support, in
most circumstances permanent cardiac pacing is not indicated or required. Some of
the more common reversible causes of bradyarrhythmia include:

● Medications (eg, beta blockers, nondihydropyridine calcium channel blockers,


antiarrhythmic medications [eg, sotalol, amiodarone]) (see "Etiology of
atrioventricular block", section on 'Medications')
● Toxic, metabolic, and electrolyte disturbances (eg, hyperkalemia, digoxin toxicity)
● Acute myocardial ischemia or infarction (see 'Post myocardial infarction' below
and "Conduction abnormalities after myocardial infarction", section on
'Management of patients with AV block')
● Cardiac trauma (eg, post-operative, blunt chest trauma, indwelling pulmonary
artery catheters)
● Infectious etiology (eg, Lyme disease)
● Subacute bacterial endocarditis with an aortic valve abscess damaging the His-
Purkinje system

Reversible causes of bradyarrhythmias and the management of reversible causes with


temporary cardiac pacing are discussed in detail separately. (See "Temporary cardiac
pacing", section on 'Reversible conditions'.)

Concurrent ICD — Some patients who have a permanent pacemaker require an


upgrade to an implantable cardioverter-defibrillator (ICD). ICDs (with the exception of
the subcutaneous ICD) have antitachycardia and antibradycardia pacing therapeutic
capabilities. In patients who have a permanent pacemaker and require an ICD or CRT
(cardiac resynchronization therapy), the pacemaker should be upgraded to the
appropriate device so that all functions can be served by one pulse generator. (See
"Subcutaneous implantable cardioverter defibrillators".)

TYPES OF PERMANENT PACEMAKER SYSTEMS

All cardiac pacemakers consist of two components: a pulse generator ( picture 1),
which provides the electrical impulse for myocardial stimulation; and one or more
electrodes (commonly referred to as leads), which deliver the electrical impulse from
the pulse generator to the myocardium. The original cardiac pacing systems consisted
of pulse generators in the abdomen with epicardial leads placed surgically. Over time,
pacemaker systems evolved to predominantly placing the pulse generator in a pre-
pectoral position with transvenously-placed endocardial leads, which were easier to
insert and required less extensive surgery. While transvenous leads may have superior
long-term function when compared with epicardial leads, there are other potential
long-term complications (eg, venous thrombosis, infection, lead malfunction, etc).
Leadless cardiac pacing systems, currently in development and in clinical trials, offer
the promise of long-term pacing capability without lead-associated complications.

Pulse generators — Pulse generators are the "battery" component of the pacemaker (


picture 1), generating the electrical impulse which is transmitted to the
myocardium, resulting in the heart beat. While the initial pulse generators were
located in the abdomen, pulse generators are currently implanted most commonly in
the infraclavicular region of the anterior chest wall. The majority are placed in a pre-
pectoral position, but in some cases a sub-pectoral position is advantageous. For most
patients with the pulse generator in this location, the impulses generated are
transmitted to the myocardium via transvenous leads. Epicardial systems are still
available and may be necessary as a result of anatomical limitations to placing a
transvenous lead(s). For the leadless systems that are in development, the pulse
generator and the electrode are one self-contained unit, which is positioned via the
femoral vein. (See 'Leadless systems' below.)

Transvenous systems — The vast majority of contemporary cardiac pacing systems


utilize transvenous electrodes (leads) for transmission of the pacing impulses from the
pulse generator to the myocardium. Transvenous leads are usually placed
percutaneously or with a cephalic cutdown, without the need for intrathoracic surgery
and inherent associated morbidities. Transvenous leads, however, are associated with
a non-trivial rate of long-term complications, including:

● Infection
● Venous thrombosis and resultant subclavian vein occlusion
● Lead malfunction
● Tricuspid valve injury (resulting in tricuspid regurgitation)

The approach to the management of long-term transvenous lead complications is


discussed separately. (See "Cardiac implantable electronic devices: Periprocedural
complications" and "Cardiac implantable electronic devices: Long-term complications"
and "Cardiac implantable electronic device lead removal".)

Epicardial systems — Epicardial cardiac pacemaker systems utilize a pulse generator


with leads that are surgically attached directly to the epicardial surface of the heart.
These systems have largely been replaced by transvenous systems for patients
requiring long-term cardiac pacing, although there is still a role for the occasional
patient with vascular access problems (eg, venous thrombosis, congenital anatomical
variations, prosthetic tricuspid valve). The major role for epicardial pacing systems in
current practice is for temporary pacing following cardiac surgery; such systems,
however, are designed as temporary systems that must be removed within the first
days to weeks following cardiac surgery.

Leadless systems — In response to the limitations of both transvenous and epicardial


pacing systems, efforts have been made to develop leadless cardiac pacing systems [2-
9]. Initial leadless systems involved multiple components but were associated with
high complication rates [2]. Subsequent leadless systems have utilized a self-contained
system which includes both the pulse generator and the electrode within a single unit
that is placed into the right ventricle via a transvenous approach [10].

● In the LEADLESS trial, which enrolled 33 patients with an indication for single-
chamber right ventricular (RV) pacing, the leadless device was successfully
implanted via transfemoral venous approach in 32 of 33 patients (97 percent) [3].
The primary endpoint, freedom from complications at 90 days, was achieved in 31
of 33 patients (94 percent). One patient suffered RV perforation and cardiac
tamponade during implantation and subsequently died. At three-year follow-up,
90 percent of the patients remained free of device-related adverse events [11].

● In the LEADLESS II trial, a prospective, non-randomized, multicenter trial of a self-


contained leadless device which enrolled 526 patients with an indication for
single-chamber RV pacing, the primary safety and efficacy endpoints were
reported in a pre-specified subset of the first 300 enrolled patients [6]. Among the
300 patients followed for six months (of whom 11 had unsuccessful efforts at
device implantation), 93 percent (270 out of 289) met the primary efficacy
endpoint of acceptable pacing capture threshold (<2 V at 0.4 milliseconds) and
sensing amplitude (R wave ≥5 mV or a value equal or greater than at
implantation), while the primary safety endpoint (freedom from device-related
adverse events) was also achieved in 93 percent of patients (280 out of 300). The
most common device-related complications were device dislodgement (1.7
percent), cardiac perforation (1.3 percent), and elevated pacing thresholds
requiring device repositioning (1.3 percent). In the LEADLESS Observational Study,
which included 470 patients following device approval, similar rates of cardiac
perforation (1.3 percent) and vascular complications (1.3 percent) were reported,
although device dislodgement (0.3 percent) did improve following a change in the
implantation protocol in April 2014 [12].

● In the Micra Transcatheter Pacing Study, which enrolled 725 patients with an
indication for single-chamber RV pacing, the leadless device was successfully
placed in 719 patients (99.2 percent) [8]. The Kaplan-Meier estimate of freedom
from device-related adverse events at six months (one of the two primary
endpoints) was 96 percent. The second primary endpoint, <2 V mean pacing
capture threshold at 0.24 millisecond pulse width, was assessed at six months in a
subset of 297 patients, among whom 292 (98.3 percent) reached the primary
endpoint. Of the approximately 12 percent of patients with elevated pacing
thresholds at the time of device implantation (high >1.0 V and very high >1.5 V),
over 85 percent had returned to normal pacing thresholds (≤1.0 V) by six months
post-implant [13]. At intermediate-term follow-up (12 months for safety
outcomes), 96 percent of patients remained free of major device-related
complications, with a significantly lower risk of major complications compared
with historical control patients who received transvenous pacemakers (hazard
ratio 0.52; 95% CI 0.35-0.77) [14].

● In the SELECT-LV study, a prospective, non-randomized study of safety and efficacy


of leadless pacing for cardiac resynchronization therapy (CRT) among patients
who "failed" conventional CRT, the leadless device was successfully implanted in
34 of 35 patients [9]. The primary efficacy endpoint (biventricular pacing on ECG at
one month) was achieved in 33 of 34 patients; however, significant procedure and
device-related complication occurred in three patients (9 percent) at the time of
implant and in eight patients (23 percent) within the first month post-implant.

Leadless cardiac pacing systems have been approved for use in Europe since 2013,
and in April 2016, the first leadless cardiac pacing system was approved for use in the
United States [15]. As of December 2016, two leadless pacemaker systems are
commercially available, with slightly different sizes and implantation requirements
[16]:

● Nanostim (St. Jude Medical), which measures 4.2 x 0.6 cm and requires an 18-
French sheath
● Micra (Medtronic), which measures 2.6 x 0.7 cm and requires a 23-French
introducer sheath

In general, leadless pacemakers have been placed via the transfemoral approach, but
in select patients the leadless pacemaker has been successfully implanted via a
transjugular approach [17].

Following device approval and introduction into general clinical practice, patients have
been prospectively enrolled in a registry to allow for postmarketing "real world"
evaluation of safety and efficacy [3,4,6,18-26].

● Among a cohort of 1817 patients from the post-approval registry, 1801 (99.1
percent) had successful implantation of the Micra leadless pacemaker at 179
centers [18]. A total of 41 major complications were reported at 30-day follow-up
(2.3 percent), comparable to the major complication rate in the pre-approval
investigational trial.

● Among 16 patients from three leadless pacemaker trials [3,4,6] who subsequently
required device removal, the device was successfully extracted in 15 of 16 patients
(94 percent), including all five patients in whom the device was in place for <6
weeks [19]. In a subsequent report on the extraction experience among 1423
worldwide recipients of the Nanostim device, among whom 73 patients
underwent attempted device retrieval (implant duration ranging from one day to
four years), 66 devices (90 percent) were successfully retrieved [20]. Of the 73
attempted retrievals, 53 were done in response to the clinical alert about potential
battery malfunction, with the other 20 patients (1.4 percent) having another
clinical indication for device retrieval. This rate of necessary revision is similar to
the reported experience with the Micra device, in which an actuarial revision rate
of 1.4 percent has also been reported [21].

● A report has been published describing the successful removal of the Nanostim
device up to nearly three years post-implant [22].

● Leadless pacemakers have been successfully implanted, with good short-term


results, in patients at high risk of device infection, including hemodialysis patients
(197 of 201 patients successfully implanted with no infections over mean 6.2
month follow-up) [23] and patients with a prior CIED infection (105 patients
implanted ≤30 days from prior infected CIED explant with no infections over mean
8.5 month follow-up) [24].

● Among a small cohort of 43 patients who had the device implanted while on
anticoagulant therapy, only one patient experienced a bleeding complication [25].
While implantation appears safe in patients treated with warfarin or another oral
anticoagulant, additional data are required to guide the optimal approach to
implantation in this setting.

In October 2016, the Nanostim manufacturer issued an alert regarding battery


malfunction occurring between 29 and 37 months post-implant and suspended
implantation of any further Nanostim devices [27]. Subsequently, in a single-center
cohort of nine patients implanted with the Nanostim device between November 2013
and April 2014, six of the nine patients experienced battery malfunction at an average
of 39 months post-implantation [28]. Complete heart block was the underlying rhythm
in three of the six patients following battery failure, although no deaths or serious
injuries were reported.
Leadless cardiac pacing holds promise as a long-term permanent cardiac pacing
option for patients requiring single ventricle (RV only) pacing and appears both safe
and efficacious in the short term. Additionally, the possibility of maintaining AV
synchrony has been explored with promising early results by using an accelerometer-
based algorithm in patients with normal sinus function but complete AV block to
provide VDD pacing [29]. However, leadless cardiac pacing may lead to RV dysfunction
and may contribute to worsening tricuspid regurgitation [30]; longer-term follow-up is
needed to assess the safety and efficacy of these devices. The potential for and
incidence of long-term deleterious effects of pacing only the RV will also need to be
assessed.

COMMON INDICATIONS

The most common indications for permanent pacemaker implantation are sinus node
dysfunction and high-grade or symptomatic atrioventricular (AV) block. Guidelines for
implantation of cardiac pacemakers have been published jointly by the American
College of Cardiology, the American Heart Association, and the Heart Rhythm Society
(ACC/AHA/HRS) [1]. Although there are occasional cases that cannot be categorized
according to these guidelines, they are, for the most part, all-encompassing and have
been widely endorsed. Similar and concordant guidelines have also been established
by the European Society of Cardiology [31].

Some indications for permanent pacing are relatively certain or unambiguous, while
others require considerable expertise and judgment. It is helpful to divide the
indications for pacemaker implantation into three specific categories, or classes, as
defined by the ACC/AHA/HRS guidelines [1]:

● Class I – Conditions in which permanent pacing is definitely beneficial, useful, and


effective. In such conditions, implantation of a cardiac pacemaker is considered
acceptable and necessary, provided that the condition is not due to a transient
cause.

● Class II – Conditions in which permanent pacing may be indicated but there is


conflicting evidence and/or divergence of opinion; class IIA refers to conditions in
which the weight of evidence/opinion is in favor of usefulness/efficacy, while class
IIb refers to conditions in which the usefulness/efficacy is less well established by
evidence/opinion.

● Class III – Conditions in which permanent pacing is not useful/effective and in


some cases may be harmful.

Sinus node dysfunction — The need for permanent pacing in patients with sinus
node dysfunction is based largely upon the correlation of bradycardia with symptoms (
table 1). While patients with a heart rate of less than 40 beats per minute or pauses
of greater than four seconds are more likely to develop symptoms, there is no
definitive threshold for heart rate (or pause length) that determines the absolute need
for a permanent pacemaker.

Class I — The following conditions are considered class I indications for pacemaker
placement [1,31]:

● Sinus bradycardia in which symptoms are clearly related to the bradycardia


(usually in patients with a heart rate below 40 beats per minute or frequent sinus
pauses).

● Symptomatic chronotropic incompetence (an impaired heart rate response to


exercise, generally defined as failure to achieve 85 percent of the age-predicted
maximum heart rate during a formal or informal stress test or the inability to
mount an age-appropriate heart rate during activities of daily living, [ie, as
documented by ambulatory monitoring]). (See "Stress testing to determine
prognosis of coronary heart disease", section on 'Heart rate response to exercise'.)

Class II — The following are considered to be class II indications for pacemaker


placement in patients with sinus node dysfunction:

● Sinus bradycardia (heart rate <40 beats per minute) in a patient with symptoms
suggestive of bradycardia, but without a clearly demonstrated association
between bradycardia and symptoms.

● Sinus node dysfunction in a patient with unexplained syncope.

● Chronic heart rates <40 beats per minute while awake in a minimally symptomatic
patient.
Patients with sinus bradycardia of lesser severity (heart rate >40 beats per minute)
who complain of dizziness or other symptoms that correlate with the slower rates are
also potential candidates for pacemaker therapy.

Sinus node dysfunction in some patients may be due to the effects of medications (eg,
antianginal or antiarrhythmic medications), a potentially reversible cause. However, if
the pertinent medications cannot be discontinued (ie, alternative therapies are
unavailable), permanent pacemaker insertion may be performed to allow for ongoing
therapy with the drugs causing sinus node dysfunction [1].

Acquired AV block — Acquired AV block is the second most common indication for


permanent pacemaker placement . Many disorders can cause acquired AV block, and
these are discussed in detail separately. (See "Etiology of atrioventricular block" and
"Third degree (complete) atrioventricular block" and "Second degree atrioventricular
block: Mobitz type II" and "Second degree atrioventricular block: Mobitz type I
(Wenckebach block)".)

Class I — The following conditions represent severe conduction disease and are
generally considered to be class I indications for pacing:

● Complete (third degree) AV block with or without symptoms


● Advanced second degree AV block (block of two or more consecutive P waves)
● Symptomatic second degree AV block, Mobitz type II
● Symptomatic second degree AV block, Mobitz type I (Wenckebach)
● Second degree AV block, Mobitz type II with a widened QRS or chronic bifascicular
block, with or without symptoms
● Exercise-induced second or third degree AV block (in the absence of myocardial
ischemia)

Some controversy exists concerning asymptomatic patients with complete heart block
and a structurally normal heart (eg, congenital complete heart block). The
ACC/AHA/HRS guidelines classify patients with congenital complete heart block and
any high-risk feature (symptoms attributed to bradycardia, wide QRS rhythm, mean
daytime heart rate <50 beats per minute, complex ventricular ectopy, or ventricular
dysfunction) as having a class I indication for permanent pacemaker implantation,
with all others with congenital complete heart block as having a class IIa indication for
permanent pacemaker implantation [1]. In contrast, no distinction is made for third
degree block of any severity in the European guidelines [31]. Nevertheless, most
practitioners consider this condition a definite indication for pacemaker placement.
(See "Congenital third degree (complete) atrioventricular block", section on
'Treatment'.)

Class II — Patients with varying degrees of acquired AV block may still benefit from
pacemaker placement. In such patients, determinations are often based upon
correlation of bradycardia with symptoms, exclusion of other causes of symptoms, and
in rare instances based on results of electrophysiology (EP) testing.

Conditions in which pacemaker placement can be considered include the following:

● Asymptomatic Mobitz II second degree AV block with a narrow QRS interval;


patients with associated symptoms or a widened QRS interval have a class I
indication for pacemaker placement.

● First degree AV block when there is hemodynamic compromise because of


effective AV dissociation secondary to a very long PR interval. (See "First degree
atrioventricular block", section on 'Management'.)

● Bifascicular or trifascicular block associated with syncope that can be attributed to


transient complete heart block, based upon the exclusion of other plausible
causes of syncope ( table 2). Alternating bundle-branch block would also fulfill
this criterion. (See "Chronic bifascicular blocks".)

AV block in some patients may be due to the effects of medications (eg, antianginal or
antiarrhythmic medications), a potentially reversible cause. However, if the pertinent
medications cannot be discontinued (ie, alternative therapies are unavailable),
permanent pacemaker insertion may be performed to allow for ongoing therapy with
the drugs causing AV block [1,32].

Post myocardial infarction — The indications for permanent pacing, including those


related to patients after an MI, are presented in detail separately. In general, our
approach is in agreement with published professional society guidelines for
implantation of a permanent cardiac pacemaker [1,33]. (See "Conduction
abnormalities after myocardial infarction".)
Neurally-mediated syncope — Evaluation of the patient with syncope can be clinically
challenging. Once a diagnosis of neurocardiogenic syncope is established or
suspected, effective treatment can be similarly challenging.

The use of pacemakers in this disorder is limited to selected patients whose syncopal
events are clearly associated with a cardioinhibitory or bradycardic event, or to those
with a probable bradycardic cause and no other explanation for syncope after a
thorough evaluation. Pacemaker treatment is usually effective in patients with an
isolated cardioinhibitory or bradycardic cause of syncope. However, since many
patients have both bradycardic and vasodepressor components, some patients with
an indication for pacemaker placement may not have a significant improvement in
symptoms with pacing. (See "Reflex syncope in adults and adolescents: Treatment".)

OTHER INDICATIONS

Congenital complete heart block — Congenital complete heart block has a variety of


causes but most commonly is due to neonatal lupus. Congenital complete heart block
can present in utero, as a neonate, or later in childhood, with management directed by
the time of presentation (ie, prenatal or postnatal) as well as the severity of symptoms.
This topic is discussed separately. (See "Congenital third degree (complete)
atrioventricular block".)

Neuromuscular diseases — A number of neuromuscular diseases are associated with


AV block, including myotonic muscular dystrophy, Kearns-Sayre syndrome, Erb's
dystrophy (limb-girdle), and peroneal muscular atrophy. Patients with these disorders
have a class I indication for pacemaker placement once any evidence of second or
third degree block develops. This is true even if the patient is asymptomatic, because
there may be unpredictably rapid progression of AV conduction disease. (See
"Inherited syndromes associated with cardiac disease".)

Due to this potential for rapid progression, patients with these disorders are
considered to have a class IIb indication for pacemaker placement even with first
degree AV block, regardless of symptoms [1,34]. Some of these patients may also
require an implantable cardioverter defibrillator (ICD) or cardiac resynchronization
therapy (CRT) [35]. (See "Primary prevention of sudden cardiac death in patients with
cardiomyopathy and heart failure with reduced LVEF".)
Long QT syndrome — High-risk patients with congenital long QT syndrome have been
treated with pacemakers to prevent ventricular arrhythmias, generally with a dual
chamber pacemaker. However, most of these patients are now treated with an
implantable cardioverter-defibrillator, which has pacing capability as well. (See
"Congenital long QT syndrome: Treatment".)

Bradycardia-induced ventricular arrhythmias — Bradycardia and/or prolonged


pauses can precipitate ventricular arrhythmias. Although this phenomenon is most
commonly associated with QT prolongation, it can occur in patients with a normal QT
interval. Patients with pause-dependent ventricular arrhythmias, with or without QT
prolongation, have an indication for pacemaker implantation. As noted above,
however, many of these patients will be treated with an implantable cardioverter-
defibrillator, which also has pacing capability. (See 'Long QT syndrome' above.)

Hypertrophic cardiomyopathy — Pacing for medically refractory, symptomatic


hypertrophic cardiomyopathy with significant resting or provoked left ventricular
outflow obstruction is now considered a class IIb indication and is not generally
recommended, particularly in patients who are candidates for septal reduction therapy
[36,37]. The role of pacing in patients with HCM, along with the utilization of
implantable cardioverter-defibrillators, is discussed in detail separately. (See
"Hypertrophic cardiomyopathy: Nonpharmacologic treatment of left ventricular
outflow tract obstruction", section on 'Pacemaker therapy'.)

Heart failure — Neither single-chamber RV pacing nor dual-chamber right heart


pacing (RA and RV) are indicated for the treatment of heart failure symptoms in
patients with heart failure. However, cardiac resynchronization therapy (CRT), also
referred to as biventricular pacing, is used to improve symptoms and survival in
patients with medically refractory advanced heart failure, nonischemic or ischemic
cardiomyopathy, and left ventricular dyssynchrony. The use of CRT is discussed in
detail separately, including the potential use of CRT in patients who have reduced left
ventricular systolic function and an indication for permanent pacing in whom pacing
will be frequent (ie, >40 percent cumulative pacing). (See "Cardiac resynchronization
therapy in heart failure: Indications".)

CLASS III: PACING NOT INDICATED


These are conditions that do not reliably improve with cardiac pacing, or are
considered to lack adequate evidence of benefit from permanent pacing. Most of
these conditions are bradyarrhythmias that are asymptomatic or due to reversible
causes .

● Syncope of undetermined etiology. This may require extensive investigation,


including ambulatory monitoring, neurologic evaluation, electrophysiologic
testing, and perhaps tilt-table testing. Cardiac pacing may be considered if no
other etiology of syncope is uncovered, and the history strongly suggests a
cardiogenic origin. In such cases, the patient must understand that permanent
pacing may not alleviate the symptoms, since no correlation between symptoms
and rhythm has been documented. In addition, if a pacemaker is implanted
because of a strong clinical suspicion that the patient's symptoms are due to a
bradyarrhythmia, in the absence of any objective evidence of conduction system
disease, reimbursement may be disallowed.

● Sinus bradycardia without significant symptoms.

● Sinoatrial block or sinus arrest without significant symptoms.

● Asymptomatic prolonged RR intervals with atrial fibrillation or other causes of


transient ventricular pause.

● Asymptomatic bradycardia during sleep.

● Asymptomatic second degree Mobitz I (Wenckebach) AV block.

● A hyperactive cardioinhibitory response to carotid sinus stimulation in the absence


of symptoms or in the presence of vague symptoms such as dizziness,
lightheadedness, or both.

● Right bundle branch block with left axis deviation without syncope or other
symptoms compatible with intermittent AV block.

● Reversible AV block, such as those associated with electrolyte abnormalities, Lyme


disease, sleep apnea, enhanced vagal tone, and some cases that occur
postoperatively. Atrioventricular block associated with drugs such as beta
blockers, diltiazem, or verapamil is not always reversible and can be associated
with underlying conduction system disease [32]. (See "Etiology of atrioventricular
block", section on 'Medications'.)

● Long QT syndrome or torsades de pointes due to reversible causes.

SOCIETY GUIDELINE LINKS

Links to society and government-sponsored guidelines from selected countries and


regions around the world are provided separately. (See "Society guideline links:
Arrhythmias in adults" and "Society guideline links: Cardiac implantable electronic
devices".)

INFORMATION FOR PATIENTS

UpToDate offers two types of patient education materials, "The Basics" and "Beyond
the Basics." The Basics patient education pieces are written in plain language, at the
5th to 6th grade reading level, and they answer the four or five key questions a patient
might have about a given condition. These articles are best for patients who want a
general overview and who prefer short, easy-to-read materials. Beyond the Basics
patient education pieces are longer, more sophisticated, and more detailed. These
articles are written at the 10th to 12th grade reading level and are best for patients who
want in-depth information and are comfortable with some medical jargon.

Here are the patient education articles that are relevant to this topic. We encourage
you to print or e-mail these topics to your patients. (You can also locate patient
education articles on a variety of subjects by searching on "patient info" and the
keyword(s) of interest.)

● Basics topic (see "Patient education: Pacemakers (The Basics)" and "Patient
education: Bradycardia (The Basics)")

● Beyond the Basics topic (see "Patient education: Pacemakers (Beyond the Basics)")

SUMMARY AND RECOMMENDATIONS


● Two general factors guide the vast majority of decisions regarding permanent
pacemaker insertion: the association of symptoms with an arrhythmia and the
potential for progression of the rhythm disturbance, which is largely dependent
on the anatomical location of the conduction abnormality. (See 'General
considerations' above.)

• Patients frequently present for consideration of pacemaker placement


because of symptoms that may be due to bradyarrhythmias (eg, dizziness,
lightheadedness, syncope, fatigue, and poor exercise tolerance). It is critical to
attempt to establish a direct correlation between symptoms and
bradyarrhythmias, which will increase the likelihood of recommending
pacemaker placement. (See 'Symptoms' above.)

• The location of an atrioventricular (AV) conduction abnormality (ie, within the


AV node or below the AV node in the His-Purkinje system) is an important
determinant of both the probability and the likely pace of progression of
conduction system disease. Disease below the AV node, in the His-Purkinje
system, is generally considered to be less stable; as a result, permanent
pacemaker placement is more likely to be recommended. (See 'Location of
conduction abnormality' above.)

● Pacemakers ( picture 1) are most commonly placed in a thoracic pre-pectoral


position and connected to one or two transvenous leads, which are positioned
endocardially. Epicardial lead placement is still a viable option for patients with
limited transvenous access. Leadless pacing systems are now available and hold
significant promise for the future. (See 'Types of permanent pacemaker systems'
above.)

● The most common indications for pacemaker implantation are sinus node
dysfunction followed by AV block. All other indications are much less common and
include neurocardiogenic syncope and iatrogenic causes (eg, post-AV node
ablation). While patients with a heart rate of less than 40 beats per minute, or
pauses of greater than four seconds, are more likely to develop symptoms, there
is no definitive threshold for heart rate (or pause length) which determines the
absolute need for a permanent pacemaker. (See 'Common indications' above.)
● With the advent of cardiac resynchronization therapy (CRT), it is important to also
take into consideration the patient's left ventricular function at the time a
pacemaker is considered. If the patient has left ventricular dysfunction and
requires frequent pacing, it may be appropriate to consider CRT or an implantable
cardioverter-defibrillator (ICD) for patients with heart failure symptoms and
reduced ejection fraction. (See "Cardiac resynchronization therapy in heart failure:
Indications".)

● Conditions with a lack of adequate evidence of benefit from permanent pacing, in


which permanent pacing is generally non indicated, include, among others,
syncope of undetermined etiology, asymptomatic sinus bradycardia,
asymptomatic first degree and second degree Mobitz I (Wenckebach) AV block,
reversible AV block, and long QT syndrome or torsades de pointes due to a
reversible cause. (See 'Class III: Pacing not indicated' above.)

ACKNOWLEDGMENT

The UpToDate editorial staff would like to thank Dr. David L. Hayes for his past
contributions as an author to prior versions of this topic review.

Use of UpToDate is subject to the Subscription and License Agreement.

REFERENCES
1. Kusumoto FM, Schoenfeld MH, Barrett C, et al. 2018 ACC/AHA/HRS Guideline on
the Evaluation and Management of Patients With Bradycardia and
Cardiac Conduction Delay: A Report of the American College of
Cardiology/American Heart Association Task Force on Clinical Practice Guidelines
and the Heart Rhythm Society. J Am Coll Cardiol 2019; 74:e51.

2. Auricchio A, Delnoy PP, Butter C, et al. Feasibility, safety, and short-term outcome
of leadless ultrasound-based endocardial left ventricular resynchronization in
heart failure patients: results of the wireless stimulation endocardially for CRT
(WiSE-CRT) study. Europace 2014; 16:681.
3. Reddy VY, Knops RE, Sperzel J, et al. Permanent leadless cardiac pacing: results of
the LEADLESS trial. Circulation 2014; 129:1466.

4. Knops RE, Tjong FV, Neuzil P, et al. Chronic performance of a leadless cardiac
pacemaker: 1-year follow-up of the LEADLESS trial. J Am Coll Cardiol 2015;
65:1497.

5. Ritter P, Duray GZ, Steinwender C, et al. Early performance of a miniaturized


leadless cardiac pacemaker: the Micra Transcatheter Pacing Study. Eur Heart J
2015; 36:2510.

6. Reddy VY, Exner DV, Cantillon DJ, et al. Percutaneous Implantation of an Entirely
Intracardiac Leadless Pacemaker. N Engl J Med 2015; 373:1125.

7. Miller MA, Neuzil P, Dukkipati SR, Reddy VY. Leadless Cardiac Pacemakers: Back to
the Future. J Am Coll Cardiol 2015; 66:1179.

8. Reynolds D, Duray GZ, Omar R, et al. A Leadless Intracardiac Transcatheter Pacing


System. N Engl J Med 2016; 374:533.

9. Reddy VY, Miller MA, Neuzil P, et al. Cardiac Resynchronization Therapy With
Wireless Left Ventricular Endocardial Pacing: The SELECT-LV Study. J Am Coll
Cardiol 2017; 69:2119.

10. Sperzel J, Burri H, Gras D, et al. State of the art of leadless pacing. Europace 2015;
17:1508.

11. Tjong FVY, Knops RE, Neuzil P, et al. Midterm Safety and Performance of a
Leadless Cardiac Pacemaker: 3-Year Follow-up to the LEADLESS Trial (Nanostim
Safety and Performance Trial for a Leadless Cardiac Pacemaker System).
Circulation 2018; 137:633.

12. Sperzel J, Defaye P, Delnoy PP, et al. Primary safety results from the LEADLESS
Observational Study. Europace 2018; 20:1491.

13. Piccini JP, Stromberg K, Jackson KP, et al. Long-term outcomes in leadless Micra
transcatheter pacemakers with elevated thresholds at implantation: Results from
the Micra Transcatheter Pacing System Global Clinical Trial. Heart Rhythm 2017;
14:685.

14. Duray GZ, Ritter P, El-Chami M, et al. Long-term performance of a transcatheter


pacing system: 12-Month results from the Micra Transcatheter Pacing Study.
Heart Rhythm 2017; 14:702.

15. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceAppro
valsandClearances/Recently-ApprovedDevices/ucm494390.htm (Accessed on Apri
l 08, 2016).

16. El-Chami MF, Merchant FM, Leon AR. Leadless Pacemakers. Am J Cardiol 2017;
119:145.

17. Saleem-Talib S, van Driel VJ, Chaldoupi SM, et al. Leadless pacing: Going for the
jugular. Pacing Clin Electrophysiol 2019; 42:395.

18. El-Chami MF, Al-Samadi F, Clementy N, et al. Updated performance of the Micra
transcatheter pacemaker in the real-world setting: A comparison to the
investigational study and a transvenous historical control. Heart Rhythm 2018;
15:1800.

19. Reddy VY, Miller MA, Knops RE, et al. Retrieval of the Leadless Cardiac Pacemaker:
A Multicenter Experience. Circ Arrhythm Electrophysiol 2016; 9.

20. Lakkireddy D, Knops R, Atwater B, et al. A worldwide experience of the


management of battery failures and chronic device retrieval of the Nanostim
leadless pacemaker. Heart Rhythm 2017; 14:1756.

21. Grubman E, Ritter P, Ellis CR, et al. To retrieve, or not to retrieve: System revisions
with the Micra transcatheter pacemaker. Heart Rhythm 2017; 14:1801.

22. González Villegas E, Al Razzo O, Silvestre García J, Mesa García J. Leadless


pacemaker extraction from a single-center perspective. Pacing Clin Electrophysiol
2018; 41:101.
23. El-Chami MF, Clementy N, Garweg C, et al. Leadless Pacemaker Implantation
in Hemodialysis Patients: Experience With the Micra Transcatheter Pacemaker.
JACC Clin Electrophysiol 2019; 5:162.

24. El-Chami MF, Johansen JB, Zaidi A, et al. Leadless pacemaker implant in patients
with pre-existing infections: Results from the Micra postapproval registry. J
Cardiovasc Electrophysiol 2019; 30:569.

25. San Antonio R, Chipa-Ccasani F, Apolo J, et al. Management of anticoagulation in


patients undergoing leadless pacemaker implantation. Heart Rhythm 2019;
16:1849.

26. Tachibana M, Banba K, Matsumoto K, Ohara M. The feasibility of leadless


pacemaker implantation for superelderly patients. Pacing Clin Electrophysiol
2020; 43:374.

27. https://www.sjm.com/en/professionals/resources-and-reimbursement/technical-r
esources/product-advisories-archive?clset=af584191-45c9-4201-8740-5409f4cf8b
dd%3ab20716c1-c2a6-4e4c-844b-d0dd6899eb3a.

28. Richter S, Döring M, Ebert M, et al. Battery Malfunction of a Leadless Cardiac


Pacemaker: Worrisome Single-Center Experience. Circulation 2018; 137:2408.

29. Steinwender C, Khelae SK, Garweg C, et al. Atrioventricular Synchronous Pacing


Using a Leadless Ventricular Pacemaker: Results From the MARVEL 2 Study. JACC
Clin Electrophysiol 2020; 6:94.

30. Beurskens NEG, Tjong FVY, de Bruin-Bon RHA, et al. Impact of Leadless
Pacemaker Therapy on Cardiac and Atrioventricular Valve Function Through 12
Months of Follow-Up. Circ Arrhythm Electrophysiol 2019; 12:e007124.

31. Brignole M, Auricchio A, Baron-Esquivias G, et al. 2013 ESC Guidelines on cardiac


pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing
and resynchronization therapy of the European Society of Cardiology (ESC).
Developed in collaboration with the European Heart Rhythm Association (EHRA).
Eur Heart J 2013; 34:2281.
32. Zeltser D, Justo D, Halkin A, et al. Drug-induced atrioventricular block: prognosis
after discontinuation of the culprit drug. J Am Coll Cardiol 2004; 44:105.

33. American College of Emergency Physicians, Society for Cardiovascular


Angiography and Interventions, O'Gara PT, et al. 2013 ACCF/AHA guideline for the
management of ST-elevation myocardial infarction: a report of the American
College of Cardiology Foundation/American Heart Association Task Force on
Practice Guidelines. J Am Coll Cardiol 2013; 61:e78.

34. Al-Khatib SM, Stevenson WG, Ackerman MJ, et al. 2017 AHA/ACC/HRS Guideline
for Management of Patients With Ventricular Arrhythmias and the Prevention of
Sudden Cardiac Death: A Report of the American College of Cardiology/American
Heart Association Task Force on Clinical Practice Guidelines and the Heart
Rhythm Society. J Am Coll Cardiol 2018; 72:e91.

35. Groh WJ. Arrhythmias in the muscular dystrophies. Heart Rhythm 2012; 9:1890.

36. Authors/Task Force members, Elliott PM, Anastasakis A, et al. 2014 ESC Guidelines
on diagnosis and management of hypertrophic cardiomyopathy: the Task Force
for the Diagnosis and Management of Hypertrophic Cardiomyopathy of the
European Society of Cardiology (ESC). Eur Heart J 2014; 35:2733.

37. Gersh BJ, Maron BJ, Bonow RO, et al. 2011 ACCF/AHA guideline for the diagnosis
and treatment of hypertrophic cardiomyopathy: executive summary: a report of
the American College of Cardiology Foundation/American Heart Association Task
Force on Practice Guidelines. Circulation 2011; 124:2761.

Topic 941 Version 36.0


GRAPHICS

Normal conduction system

Schematic representation of the normal intraventricular conduction system (His-Purkinje system). The
Bundle of His divides into the left bundle branch and right bundle branch. The left bundle branch
divides into anterior, posterior, and, in some cases, median fascicles.

AV: atrioventricular; RA: right atrium; LA: left atrium; RV: right ventricle; LV: left ventricle.

Graphic 63340 Version 6.0


Examples of cardiac pacemaker pulse generators

Examples of cardiac pacemaker pulse generators commonly used in practice in 2015.

Graphic 104720 Version 1.0


Indications for pacing for sinus node dysfunction

Pacemaker not
Pacemaker necessary Pacemaker probably necessary
necessary

Symptomatic bradycardia Symptomatic patients with sinus node dysfunction Asymptomatic sinus
with documented rates of <40 bpm without a node dysfunction
clear-cut association between significant
symptoms and the bradycardia

Symptomatic sinus bradycardia due to


long-term drug therapy of a type and
dose for which there is no accepted
alternative

Graphic 70519 Version 2.0


Indications for pacing in multifascicular block

Pacemaker not
Pacemaker necessary Pacemaker probably necessary
necessary

Symptomatic patients with fascicular block Patients with syncope and bifascicular Asymptomatic fascicular
and significantly prolonged H-V interval by or trifascicular block with other block without AV block
electrophysiologic study etiologies of syncope excluded

Symptomatic patients with block distal to His Pacing-induced block distal to His at Asymptomatic fascicular
at atrial paced rates of less than 100-120 atrial paced rates of less than 130 bpm block and first degree AV
bpm block

Symptomatic patients with bifascicular block Asymptomatic patients with fascicular


and intermittent type II second degree AV block and intermittent type II second
block or third degree AV block degree or third degree AV block

Graphic 80379 Version 1.0

Contributor Disclosures
Mark S Link, MD Patent Holder: Tufts Medical Center [Chest wall protector]. N A Mark Estes,
III, MD Consultant/Advisory Boards: Medtronic [Arrhythmias (Pacemakers and ICDs)]; St Jude
Medical [Arrhythmias (Pacemakers and ICDs)]; Abbott [Arrhythmias (Pacemakers and ICDs)];
Boston Scientific [Arrhythmias (Pacemakers and ICDs)]. Susan B Yeon, MD, JD, FACC Nothing to
disclose
Contributor disclosures are reviewed for conflicts of interest by the editorial group. When found,
these are addressed by vetting through a multi-level review process, and through requirements
for references to be provided to support the content. Appropriately referenced content is
required of all authors and must conform to UpToDate standards of evidence.
Conflict of interest policy

You might also like